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Development of stability-indicating methods for determination of Sulpiride in presence of its degradation products in bulk and dosage forms.

Maha Farouk, Lobna Abd El Aziz1, Amal Mahmoud Ekram Hany

Simple, accurate, sensitive, and precise UV spectrophotometric and chemometric methodswere developed for determination of Sulpiride (SLP) in presence of its degradation products. Two spectrophotometric methods were developed, namely, double divisor ratio spectra (DDRD) and ratio subtraction (RS); the linearity range was 20-200 ug.ml-1 for both spectrophotometric methods, with mean percentage recoveries of 99.51±0.24 and 99.73±0.32 for the double divisor ratio spectra and ratio subtraction method respectively. The developed chemometric-assisted spectrophotometric methods were the principle component regression (PCR) and partial least squares (PLS) methods. The linearity range was also 20-100 ug.ml-1 for both methods while the mean percentage recoveries were found to be 99.63 ±0.22 and 99.60 ±0.26 for the PCR and PLS methods respectively. The developed methods were successfully applied for determination of SLP in bulk powder, laboratory-preparedmixtures and in dosage form. The results obtained were compared to the reported spectrophotometric method; there was no significant difference between the proposed methods and the reported method. 2013 Trade Science Inc. - INDIA